# K030800: Electromed Reusable Neurostimulation Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Eletromed, Inc.
- Decided: Jun 11, 2003 after 90 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903402 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963125: M and R Reusable Electrodes (Multiple), M & R Mfg., Inc. (1997) Summary page 1.
- K932849: Pmi Tens Electrode, Pepin Mfg., Inc. (1994) Summary page 1.

## Indications for use
Electromed Reusable Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electromed Reusable Electrodes are designed and intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) of PGF (Pulsed Galvanic Stimulation). These electrodes will include the precaution statement: Federal Law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K030800
Methodology: https://510kreport.com/methodology